PDF(Pubmed)
Abstract：
UNASSIGNED: HIV Vaccine Trials Network (HVTN) 704/085, a placebo-controlled clinical trial assessing the efficacy of VRC01 broadly neutralizing antibody infusion for HIV prevention, offered oral preexposure prophylaxis (PrEP) as the standard of prevention at no cost to participants.
UNASSIGNED: We characterized features of- identified factors associated with- PrEP initiation and discontinuation, and the effects of PrEP initiation on HIV incidence.
UNASSIGNED: Of 2221 participants, 31.8% initiated oral PrEP during study follow-up, with the highest proportion of PrEP initiations in Brazil (83.2%) and the United States (US) (54.2%). Prior PrEP use was associated with PrEP initiation (hazard ratio [HR], 2.22 [95% confidence interval {CI}, 1.25-3.95]). Participants from Switzerland (HR, 0.5 [95% CI, .3-1.0]) and Peru (HR, 0.08 [95% CI, .06-.1]) had lower likelihood of PrEP initiation compared to the US, while participants from Brazil had higher likelihood (HR, 2.6 [95% CI, 2.0-3.3]). In the US, PrEP initiation was lower in areas with higher unmet need for PrEP (HR, 0.9 per 5 units [95% CI, 0.8-1.0]). PrEP initiators had 58% less risk of acquiring HIV than PrEP noninitiators. Among PrEP initiators, 34.4% discontinued PrEP during study follow-up. Brazil had 63% less likelihood of PrEP discontinuation than the US (HR, 0.37 [95% CI, .22-.60]).
UNASSIGNED: When included as standard of prevention in HVTN 704/085, oral PrEP utilization patterns mirrored those observed in real-life settings. Variable effects of oral PrEP on HIV outcomes in clinical trials may be expected based on regional differences in oral PrEP use.
UNASSIGNED: We characterized features of- identified factors associated with- PrEP initiation and discontinuation, and the effects of PrEP initiation on HIV incidence.
UNASSIGNED: Of 2221 participants, 31.8% initiated oral PrEP during study follow-up, with the highest proportion of PrEP initiations in Brazil (83.2%) and the United States (US) (54.2%). Prior PrEP use was associated with PrEP initiation (hazard ratio [HR], 2.22 [95% confidence interval {CI}, 1.25-3.95]). Participants from Switzerland (HR, 0.5 [95% CI, .3-1.0]) and Peru (HR, 0.08 [95% CI, .06-.1]) had lower likelihood of PrEP initiation compared to the US, while participants from Brazil had higher likelihood (HR, 2.6 [95% CI, 2.0-3.3]). In the US, PrEP initiation was lower in areas with higher unmet need for PrEP (HR, 0.9 per 5 units [95% CI, 0.8-1.0]). PrEP initiators had 58% less risk of acquiring HIV than PrEP noninitiators. Among PrEP initiators, 34.4% discontinued PrEP during study follow-up. Brazil had 63% less likelihood of PrEP discontinuation than the US (HR, 0.37 [95% CI, .22-.60]).
UNASSIGNED: When included as standard of prevention in HVTN 704/085, oral PrEP utilization patterns mirrored those observed in real-life settings. Variable effects of oral PrEP on HIV outcomes in clinical trials may be expected based on regional differences in oral PrEP use.
摘要：
■HIV疫苗试验网络（HVTN）704/085，一项安慰剂对照临床试验，评估VRC01广泛中和抗体输注对HIV预防的功效，参与者免费提供口服暴露前预防（PrEP）作为预防标准。
■我们表征了与PrEP启动和停药相关的已识别因素的特征，以及PrEP启动对HIV发病率的影响。
■在2221名参与者中，31.8％的人在研究随访期间开始口服PrEP，在巴西（83.2%）和美国（54.2%）的PrEP初始化比例最高。先前使用PrEP与开始使用PrEP相关(风险比[HR]，2.22[95%置信区间{CI}，1.25-3.95])。来自瑞士的参与者(HR，0.5[95%CI，.3-1.0])和秘鲁(HR，0.08[95%CI，.06-.1])与美国相比，PrEP启动的可能性较低，而来自巴西的参与者有更高的可能性(HR，2.6[95%CI，2.0-3.3]）。在美国,在未满足PrEP需求较高的地区，PrEP的起始率较低(HR，每5个单位0.9个[95%CI，0.8-1.0])。PrEP发起者获得HIV的风险比PrEP非发起者低58％。在PrEP发起人中，34.4%在研究随访期间停止PrEP。巴西停药的可能性比美国低63%(HR，0.37[95%CI，.22-.60]）。
■当作为HVTN704/085中的预防标准时，口头PrEP利用模式反映了在现实生活中观察到的模式。根据口服PrEP使用的区域差异，可以预期口服PrEP对临床试验中HIV结局的可变影响。
■我们表征了与PrEP启动和停药相关的已识别因素的特征，以及PrEP启动对HIV发病率的影响。
■在2221名参与者中，31.8％的人在研究随访期间开始口服PrEP，在巴西（83.2%）和美国（54.2%）的PrEP初始化比例最高。先前使用PrEP与开始使用PrEP相关(风险比[HR]，2.22[95%置信区间{CI}，1.25-3.95])。来自瑞士的参与者(HR，0.5[95%CI，.3-1.0])和秘鲁(HR，0.08[95%CI，.06-.1])与美国相比，PrEP启动的可能性较低，而来自巴西的参与者有更高的可能性(HR，2.6[95%CI，2.0-3.3]）。在美国,在未满足PrEP需求较高的地区，PrEP的起始率较低(HR，每5个单位0.9个[95%CI，0.8-1.0])。PrEP发起者获得HIV的风险比PrEP非发起者低58％。在PrEP发起人中，34.4%在研究随访期间停止PrEP。巴西停药的可能性比美国低63%(HR，0.37[95%CI，.22-.60]）。
■当作为HVTN704/085中的预防标准时，口头PrEP利用模式反映了在现实生活中观察到的模式。根据口服PrEP使用的区域差异，可以预期口服PrEP对临床试验中HIV结局的可变影响。
